The research and development of cell therapy product candidates require an exceptional team of people with scientific and clinical expertise across a range of disciplines. We seek to forge collaborations with leading strategic partners, key researchers, and top medical centers to accelerate the development of our first-in-class product candidates and proprietary iPSC platform.
In April 2020, we entered into a collaboration with Janssen Biotech, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop iPSC-derived CAR NK and CAR T-cell product candidates for the treatment of cancer. Under the collaboration, Janssen will contribute proprietary antigen binding domains directed to up to four tumor-associated antigen targets. We will research and construct iPSC-derived CAR NK and CAR T-cell collaboration candidates directed to each of these antigen targets, and conduct preclinical development to enable the submission of an IND application for each collaboration candidate. Janssen has the right to exercise an exclusive option and obtain an exclusive license for the clinical development and commercialization of each collaboration product, and we are primarily responsible for the manufacture of such collaboration product. For each collaboration product, upon attaining clinical proof-of-concept, we have the right to elect to co-commercialize with Janssen in the United States subject to sharing equally in the profits and losses with Janssen.
In September 2018, we entered into a collaboration with ONO Pharmaceutical to develop and commercialize two off-the-shelf CAR-T cell product candidates. The collaboration brings together ONO’s global leadership and proven track record in oncology and our expertise with induced pluripotent stem cells (iPSC) and CAR-T cell therapies. Under the collaboration, using our proprietary iPSC platform, the two CAR T-cell collaboration candidates will each be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, insert a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality. Fate retains global responsibility for one of the candidates, with ONO having an option to assume responsibilities in Asia. For the second candidate, ONO has an option to assume global responsibility, with Fate retaining the right to co-develop and co-commercialize in the United States and Europe.
In July 2015, we entered into a research collaboration with the University of Minnesota led by Jeffrey S. Miller, M.D., Deputy Director of the Masonic Cancer Center and the Deputy Director of the Clinical and Translational Science Institute at the University of Minnesota. Under the collaboration, we advanced the first-ever iPSC-derived cell therapy, FT500, and the first-ever engineered iPSC-derived cell therapy, FT516, into clinical development in the United States. We continue to work in collaboration with the University of Minnesota on the research and development of off-the-shelf, iPSC-derived CAR NK cell cancer immunotherapies.
In September 2016, we entered into a research collaboration with the Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., Director of the Center for Cell Engineering and the Stephen and Barbara Friedman Chair at Memorial Sloan Kettering Cancer Center, for the development of iPSC-derived T-cell immunotherapies. Through this collaboration, we have sought to leapfrog the current patient-specific approach to T-cell immunotherapy by uniting the research, preclinical and manufacturing activities of the two groups. We are developing FT819, an off-the-shelf CAR T-cell cancer immunotherapy derived from a clonal engineered master iPSC line with complete elimination of TCR expression and a novel 1XX CAR targeting CD19 inserted into the TRAC locus, under our collaboration with Memorial Sloan Kettering Cancer Center. Together, these features are intended to induce antigen-specific cytotoxicity, enhance CAR activity through TRAC-regulated expression and completely eliminate TCR expression to mitigate GvHD.
In December 2017, we entered into a research collaboration with University of California San Diego led by Dan S. Kaufman, M.D., Ph.D., Professor of Medicine, Division of Regenerative Medicine, and Director of Cell Therapy at UCSD. Under the collaboration, we evaluated chimeric antigen receptor (CAR) constructs containing transmembrane and co-stimulatory domains optimized for antigen-specific activation and effector function in NK cells. The specific goals of the collaboration are to develop off-the-shelf, CAR-targeted NK cell cancer immunotherapies using clonal engineered master pluripotent cell lines.
In January 2017, we entered into a research collaboration with Oslo University Hospital being led by Dr. Karl-Johan Malmberg, a leading expert in NK cell biology and killer cell immunoglobulin-like receptors. Our specific goals of this collaboration are to identify NK cell modifications that promote persistence and enhanced anti-tumor potency, and to create new iPSC-derived NK cell product candidates for development.